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    Novavax Says Vaccine Protects Against Deadly Bird Flu

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    Novavax Says Vaccine Protects Against Deadly Bird Flu

    Post by sang_garuda on Thu Aug 28, 2008 8:30 am

    Novavax Inc. said its experimental vaccine spurred an immune response in humans that can protect against a deadly strain of bird flu linked to more than 100 deaths.

    In the study, 160 patients each received two injections, in doses ranging from 15 to 90 micrograms. At the highest dose, the vaccine produced a response against one version of the lethal H5N1 bird flu in 94 percent of patients, Novavax said in a statement today.

    Novavax, based in Rockville, Maryland, has been working with General Electric Co. to develop a vaccine that can be mass- produced quickly. How Novavax might profit from such a product remained unclear, said Ken Trbovich, an analyst with RBC Capital Markets in Denver, and Novavax fell today in Nasdaq trading.

    ``The technology may be good, but it doesn't mean they will prevail in winning a large government contract,'' Trbovich said yesterday in a telephone interview. ``Most of the contracts over the last two years have occurred with very large, established players in the vaccine field.''

    Novavax declined 6 cents, or 2 percent, to $2.91 at 4:30 p.m. in Nasdaq Stock Market composite trading. General Electric fell 5 cents, or less than a percent, to $28.27 in New York Stock Exchange composite trading.

    Outbreaks of lethal avian flu have spread from birds to humans in 15 countries, mostly in Asia, and are ``not expected to diminish significantly in the short term,'' according to the U.S. Centers for Disease Control and Prevention's Web site.

    ``What we've shown in this study is that the vaccine is immunogenic in humans,'' said Rahul Singhvi, Novavax's president and chief executive officer, in an interview. ``It will allow countries around the world to produce a custom vaccine on demand within their own borders.''

    Indonesian Strain

    There have been 385 confirmed cases of bird flu in humans, resulting in 243 deaths, from late 2003 through June 19 -- the latest data available -- according to the World Health Organization's Web site. The study involved what is known as the Indonesian strain of H5N1. That version has accounted for 135 cases, mostly fatal, of avian flu in humans, according to Novavax.

    Novavax's process, which uses insect-cell cultures, avoids the need to grow viruses in eggs by making vaccines from particles that mimic viruses. With its process, Novavax can produce seven to 10 times as much vaccine in the same time as techniques that rely on eggs or cells from mammals, the company said. Novavax said it can make vaccine within 10 to 12 weeks of identifying a strain.

    `Good Progress'

    ``This data milestone marks good progress in the viability of Novavax's vaccine,'' said Peter Ehrenheim, president and CEO of life sciences for GE Healthcare, based in Chalfont St. Giles, near London, in a statement.

    Other drug companies, including GlaxoSmithKline Plc and Sanofi-Aventis SA, are developing vaccines that could be produced rapidly during a flu pandemic. Traditional flu shots are made in chicken eggs, a process that can take up to six months after a strain of the virus is identified. Scientists have predicted that an avian flu strain could spread across the globe within days.

    Safe to Continue

    ``The data are encouraging that this new vaccine approach can help prevent pandemic influenza,'' said Robert B. Belshe, an immunologist and infectious disease specialist at the Saint Louis University School of Medicine, who served on an independent safety monitoring board for the study, in a statement.

    No ``serious'' side effects have been reported for the Novavax vaccine study and an independent monitoring board has supported continuing the study, Novavax said in its statement. Complete safety data for the study aren't yet available, the company said.

    Novavax also is conducting two preliminary studies of a vaccine for seasonal influenza, which causes more than 500,000 deaths worldwide annually. One of the studies will test the vaccine on healthy young adults and another on people age 65 and over. Results of those studies are expected in late 2008 or early 2009.


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